FLUCONAZOLE SANDOZ fluconazole 200 mg/100 mL injection

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

fluconazole, Quantity: 2 mg/mL

Доступно од:

Sandoz Pty Ltd

INN (Међународно име):

Fluconazole

Фармацеутски облик:

Injection, solution

Састав:

Excipient Ingredients: sodium chloride; hydrochloric acid; water for injections

Пут администрације:

Intravenous

Јединице у пакету:

1

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Fluconazole Sandoz Injection is indicated in adults and children for the following conditions only if fluconazole can not be administered orally. For treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin B. Note. Data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin B in the treatment of the acute phase of cryptococcal meningitis. Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (AIDS). Treatment of oropharyngeal and oesophageal candidiasis in AIDS and other immunosuppressed patients. Secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (HIV) infection. Serious and life threatening Candida infections in patients who are unable to tolerate amphotericin B. Note. It remains to be shown that fluconazole is as effective as amphotericin B in the treatment of serious and life threatening Candida infections. Until such data are available, amphotericin B remains the drug of choice. Vaginal candidiasis, when topical therapy has failed. Treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. Usually, topical therapy should be attempted first because oral and intravenous therapy has a less favourable ratio of benefits to risks. (See Adverse Effects.)

Резиме производа:

Visual Identification: Clear, colourless solution, free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Статус ауторизације:

Registered

Датум одобрења:

2005-07-27

Информативни летак

FLUCONAZOLE SANDOZ
®
1
FLUCONAZOLE SANDOZ
®
_Fluconazole injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fluconazole Sandoz
injection.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT FLUCONAZOLE
SANDOZ IS USED FOR
This medicine is used to treat
_ _
certain
fungal and yeast infections.
_ _
It contains the active ingredient
fluconazole.
_ _
Fluconazole belongs to a group of
medicines called
_ _
azole antibiotics.
It works by preventing the growth of
fungal and yeast organisms causing
your infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor’s prescription.
_ _
BEFORE YOU ARE GIVEN
FLUCONAZOLE SANDOZ
_WHEN YOU MUST NOT BE GIVEN _
THIS MEDICINE SHOULD NOT BE GIVEN
IF YOU HAVE AN ALLERGY TO:
•
fluconazole, the active ingredient,
or to any of the other ingredients
listed at the end of this leaflet
under Product Description
•
any other similar medicines
related to fluconazole such as
miconazole, ketoconazole or
clotrimazole.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
YOU MUST NOT BE GIVEN FLUCONAZOLE
SANDOZ INJECTION IF YOU ARE TAKING
ANY OF THE FOLLOWING MEDICINES:
•
terfenadine or astemizole (a
medicine used to treat allergies)
•
cisapride (a medicine used to treat
stomach problems
•
erythromycin (a medicines used
to t

Карактеристике производа

211202-Fluconazole Sandoz-pi
Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION
FLUCONAZOLE SANDOZ
® (FLUCONAZOLE) INJECTION
1
NAME OF THE MEDICINE
Fluconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Fluconazole Sandoz vials contains 2 mg/mL fluconazole.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Fluconazole Sandoz injection 2 mg/mL is a clear colourless solution,
free from visible particles.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Fluconazole Sandoz injection is indicated in adults and children for
the following conditions
only if fluconazole cannot be administered orally:
Orally for treatment of cryptococcal meningitis in patients who are
unable to tolerate
amphotericin B.
_Note. _
Data suggest that the clinical efficacy of fluconazole is lower than
that
of amphotericin B in the treatment of the acute phase of cryptococcal
meningitis.
Maintenance therapy to prevent relapse of cryptococcal meningitis in
patients with acquired
immune deficiency syndrome (AIDS).
Treatment
of
oropharyngeal
and
oesophageal
candidiasis
in
AIDS
and
other
immunosuppressed patients.
Secondary prophylaxis of oropharyngeal candidiasis in patients with
human immunodeficiency
virus (HIV) infection.
Serious and life threatening Candida infections in patients who are
unable to tolerate
amphotericin B.
_Note._
It remains to be shown that fluconazole is as effective as
amphotericin
B in the treatment of serious and life threatening Candida infections.
Until such data are
available, amphotericin B remains the drug of choice.
Vaginal candidiasis, when topical therapy has failed.
Treatment of extensive tinea corporis, extensive tinea cruris and
extensive tinea pedis
infections in immunocompetent patients in whom topical therapy is not
a practical treatment
option. Usually, topical therapy should be attempted first because
oral therapy has a less
favourable ratio of benefits to risks. (See Section 4.8 Adverse
effects (Undesirable effects))
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Th